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CTRI Number  CTRI/2019/09/021203 [Registered on: 12/09/2019] Trial Registered Prospectively
Last Modified On: 06/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Clinical effectiveness of TR-01 in providing relief in productive, non-productive and bronchial cough. 
Scientific Title of Study   Parallel arm, prospective, randomized study for clinical effectiveness of TR-01 in providing relief in productive, non-productive and chronic bronchial cough with throat irritation. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/19-20/005 Ver. 1.0 dated 20 July 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidyadhar Kumbhar 
Designation  Consultant 
Affiliation  Sunad Ayurved 
Address  Sunad Ayurved Wolf colony, Devghar Society, Chinchwad, Pune 33

Pune
MAHARASHTRA
411033
India 
Phone  9960075536  
Fax    
Email  dr.vidyadhar24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Dipika Patil 
Designation  Manager 
Affiliation  Mprex Healthcare 
Address  414, Nisarg Plaza, Bhumkar Nagar, Wakad, Pune 411057

Pune
MAHARASHTRA
411057
India 
Phone  7709307004  
Fax    
Email  clinical@mprex.in  
 
Details of Contact Person
Public Query  
Name  Mr Ashish Nagaonkar 
Designation  Partner 
Affiliation  M.N.Pharmaceuticals  
Address  27,Madhumansion,Old P.B.Road,NIPANI 591237.

Belgaum
KARNATAKA
591237
India 
Phone  7892647421  
Fax    
Email  pharmaceuticals.m.n@gmail.com  
 
Source of Monetary or Material Support  
MN Pharmaceuticals 
 
Primary Sponsor  
Name  MN Pharmaceuticals  
Address  R. S.NO 51/1B, KLE CBSE CORNER BUDALMUKH ROAD, NIPANI. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vidyadhar Kumbhar  Sunad Ayurved  Wolf Colony, Devghar Society Chinchwad Pune 411033
Pune
MAHARASHTRA 		 9960075536

dr.vidyadhar24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Royal Pune Independent Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  TR-01 cough syrup   10ml thrice a day for minimum 4 and maximum 8 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and females between 18 to 65 years age. 2. Patients diagnosed as having cough with one of the following conditions
a. Patients having dry cough (less than 14 days) of any origin
b. Patients having acute moderate to severe wet (productive) cough production at a maximum of 14 days prior to screening of any origin
c. Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for one consecutive months for more than two consecutive years).
3. Presenting symptoms of Throat Pain, throat redness, Throat irritation/itching, (Fever if present).
4. Not under any antibacterial or antiviral treatment before recruitment.
5. Patients ready to abstain from using any drug (which will affect the study outcome) other than Investigational
6. Product for the treatment of the studied condition during the study period except in cases if patient’s condition worsen (At the discretion of study physician antibiotic will be prescribed if required).
7. Ready to abstain from administration of any herbal or ayurvedic treatment or gargles directed to ease coughing or throat parameters, tea, coffee. Cooperative and understanding skills.
8. Patient willing and able to provide a signed written informed consent prior to any study – specific procedure.
9. Patients who in opinion of the investigator will be able to comply with the study requirements. 
 
ExclusionCriteria 
Details  1. Patients with H/O underlying lung pathology such as lung abscess, cystic fibrosis.
2. Patients with known hypersensitivity to ingredients of Investigational Products
3. Patients with H/O Myocardial Infarction (MI) within 4 weeks prior to enrollment
4. Patients with immediate life threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease.
5. Patients with uncontrolled Hypertension.
6. Alcohol, smoke and drug abusers will be excluded. Occasional users of cigarettes and alcohol may participate in the study as per the investigators discretion. Such participants should be instructed from restricting the use of cigarettes / alcohol during the study participation period.
7. Subjects on any other herbal therapy / supplement for cough
8. Patients with history of hepatic impairment 9. Pregnancy, lactation and female patients not using acceptable contraceptive measures. 11. Participation in another clinical trial in the past 3 months
10. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of herbal syrup with respect to symptomatic relief in patient suffering from cough.
Change in the wet cough severity and frequency score
Change in the dry cough severity and frequency score
Change in the bronchial cough severity and frequency score 		 At day 0, 1,4 and at day 8. Minimum 4 days and maximum 8 days or up to complete recovery (whichever is earlier) compared to the baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
Leicester Cough Questionnaire
Change in the Chest discomfort score
Change in score of throat pain
Change in throat irritation/itching
Throat mucosa redness
Fever Measure of drowsiness Physician’s global assessment of efficacy
Subject’s global assessment of efficacy
Chest X-ray analysis from baseline to end of treatment (brochial cough only)
Safety assessed by Adverse Events 		 At day 0, 1,4 and at day 8. Minimum 4 days and maximum 8 days or up to complete recovery (whichever is earlier) compared to the baseline. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   16/09/2019 
Date of Study Completion (India) 28/09/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   TR-01 is a well developed polyherbal cough syrup formulation with potential to work in productive, non productive and bronchial cough.
The present study aims at conducting clinical validation of the relief in cough and related symptoms, safety, tolerability and adverse effects if any.

 
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